Election of the Optimal Moment of Colecistectomy After Mild Biliary

Status Completed

Clinical Trial Summary

Introduction Acute pancreatitis is the third gastrointestinal cause of hospital admission. It is estimated that 35-60% have a biliary origin, and most of them are mild. After a mild acute biliary pancreatitis (ABP), there is a high risk of recurrence of others biliary events. 15-20% of patients will suffer another pancreatitis, cholangitis, choledocolithiasis, or cholecystitis. Therefore, is necessary a definitive treatment. Although it is suggested to perform cholecystectomy early, there is still insufficient scientific evidence on this subject. All publications have biases and do not allow establish recommendations. In addition, the usual clinical practice tends to postpone the cholecystectomy, because of doubts about the safety of early intervention and for hospital logistical reasons. On the other hand, is discussing if early cholecystectomy carried out more persistence of residual cholelithiasis, explains for the pathophysiology of the ABP. Finally, it is important to mention, that in our environment 25% of the patients with an ABP are more than 75 years old. There are not any trial that includes this age group. Objectives Demonstrate that early cholecystectomy is feasible in all patients, including elderly patients, and decreases the number of readmissions for other biliary events. Material and Methods It is being done a multicenter prospective randomized trial. After an ABP, patients are randomized in two treatment branches. Group A is cholecystectomy within the first week after the ABP. Group B four weeks later. There are collect data from demographic information, comorbidities, biliary events before the surgery, residual choledocolithiasis, difficulty of the surgical technique, postoperative complications and patients are follow-up for 6 months. To obtain a representative sample of the population, we consider it appropriate to include all age groups, including patients older than 75 years. Expected results With this study we pretend to demonstrate that early cholecystectomy is feasible and safe. It does not increase the number of residual choledocolithiasis, and prevents readmissions for new biliary events.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04625712
Study type	Interventional
Source	Consorci Sanitari Integral
Contact
Status	Completed
Phase	N/A
Start date	January 1, 2017
Completion date	December 31, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Election of the Optimal Moment of Colecistectomy After Mild Biliary Pancreatitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms